FDA device listing
Tandem Mobi Adhesive Sleeve
FDA device listing 1094307873 · Model Solution
Key facts
| Proprietary names | Tandem Mobi Adhesive Sleeve |
|---|---|
| Owner/operator | Model Solution |
| Owner/operator number | 10057287 |
| Product codes | KGX |
| Device names | KGX - Tape And Bandage, Adhesive |
| Device class | Class I |
| Classification regulations (21 CFR) | 880.5240 |
| Review panels | General Hospital |
| Registered establishments | MODEL SOLUTION |
| Establishment registrations | 3009803802 |
| FEI numbers | 3009803802 |
| Establishment operations | Contract Manufacturer, Foreign Exporter |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database